MAUDE Adverse Event Report: ETHICON INC. VISTASEAL DUAL APPLICATOR; FIBRIN SEALANT PREPARATION DEVICE

Model Number VSTAS1

Device Problems Component Missing (2306); Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and a fibrin sealant preparation device was used.The product was opened for the case and before adding the item to the surgical field it was noted that the plastic part of packaging had a large crack and missing piece.This rendered the item no longer sterile.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: what is the lot number? a4ydf00461 expires 06/17/2023.Which component within the kit was found to be cracked (pre-filled syringe packaging, or dual applicator tip packaging)? the event report says ¿the plastic part of the packaging¿.Which component was missing within the damaged packaging? n/a.Please clarify if the device available to be returned for evaluation? no ¿ it was inadvertently discarded per the operating room.Please clarify to which address can the replacement be sent over? n/a.Are there pictures of the damaged packaging available? not to my knowledge.Please clarify if the damaged product is available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? the product is not available for return.Which component within the kit was found to be cracked (pre-filled syringe packaging, or dual applicator tip packaging)? it was the dual applicator.The vstas1 lot number that corresponds with vst10 lot a4ydf00461 is 2676877.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is the delivery or order number of the shipment for the product available? are they any pictures of the shipping material the cracked dual applicator arrived in? was the damaged limited to the product packaging with no visible damage to the shipper container? was there any component missing from the cracked dual applicator packaging? this report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested, and the following was obtained: 1.Is the delivery or order number of the shipment for the product available? no 2.Are they any pictures of the shipping material the cracked dual applicator arrived in? no 3.Was the damaged limited to the product packaging with no visible damage to the shipper container? limited to the product packaging.4.Was there any component missing from the cracked dual applicator packaging? no ¿ nothing missing.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: distribution investigation summary: the customer was shipped (b)(4) units over 1 order.No special / extraordinary events / observations were identified during the receiving, storage, picking, packing, or shipping of the lot and order(s) detailed above.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: h6 medical device problem code - component missing (a020602) corrected information: additional information received stating that there was nothing missing within the package.

• Brand Name: VISTASEAL DUAL APPLICATOR
• Type of Device: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): TESSY PLASTICS CO. LTD; 509 ren qing road; pudong 20120 1; CH 201201
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14396137
• MDR Text Key: 300130319
• Report Number: 2210968-2022-03684
• Device Sequence Number: 1
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: 10705031462533
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: BK180287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: VSTAS1
• Device Catalogue Number: VSTAS1
• Device Lot Number: 2676877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1